Radiation in tissue banking : basic science and clinical applications of irradiated tissue allografts

This important book discusses the need for gamma irradiation in the processing of tissue allografts. With particular emphasis on tissue banking in the Asia-Pacific region, it covers a wide range of issues in tissue banking, including the basic science of radiation, quality control of the irradiation process, and clinical applications of irradiated bone grafts and amnions. A compulsory textbook for the well-regarded Singapore-based IAEA/NUS Diploma Course in Tissue Banking, it is also a useful guide for tissue bankers in establishing quality systems in their banks. Whether they be tissue banking students, tissue graft producers, radiation scientists, or transplantation surgeons, readers of this book will discover the latest developments in this exciting interdisciplinary field. Doody Review Services Reviewer: Linda S Martin, BA(Mid-America Transplant Services) Description: This book introduces clinicians to the basic principles of radiation in tissue banking. Various contributors have collaborated to provide background, history, and scientific principles used in tissue banking in Asian-Pacific, Latin American, Korean, African, and European countries. Purpose: The primary purpose is to provide one reference for tissue bankers who procure and process tissue grafts, for radiation scientists who sterilize the grafts, and for transplantation surgeons who use the products. The book is noted to also be useful for training and for reviewing recent developments in the field. The book likely fills a need in the targeted countries. The principles are basic and the book is likely not comprehensive enough for those familiar with the techniques and processes or for those looking for detailed information on preparing and processing grafts. The book does meet the author's objectives in addressing the controversies surrounding gamma irradiation and its role in tissue banking. Audience: According to the author, this book is written for anyone involved in the field -- from those preparing the grafts to the surgeons implanting the grafts as well as those training in the tissue banking field. For those involved in the tissue banking field in Canada or the United States, the information is basic and not as detailed or as up-to-date with the latest technologies or tissue banking standards. The authors appear well versed in the subject matter and technology available in their respective countries. Features: The book covers basic tissue banking principles, sterility issues, procurement and processing of various grafts, and the utilization of different types of grafts, while outlining current practices in Asia-Pacific, Latin America, Africa, Korea, and Europe. However, it suffers from the inclusion of information and standards that are somewhat outdated and the presentation of basic principles that would be too simplistic for effective training. Assessment: This book presents basic information about tissue banking, its history, and the current state of the art in certain areas of the world. Compared to references available to clinicians or implant surgeons, the information is very basic. The book provides a comprehensive history of the development of tissue banking systems in parts of the world that rely on radiation to enhance graft safety. Contents......Page 14 Foreword Chairman of BATAN & Director-General of NM......Page 6 Foreword from the Director-General of the Malaysian Nuclear Agency (NM)......Page 8 Preface Aziz Nather......Page 10 List of Contributors......Page 18 Part I TERMINAL STERILIZATION OF TISSUE GRAFTS......Page 24 Types of Sterilization......Page 26 Gravitational method......Page 27 Microwave irradiation......Page 28 Ethylene oxide......Page 29 Supercritical carbon dioxide......Page 30 Glutaraldehyde......Page 31 References......Page 32 Introduction......Page 34 Sources of Contamination......Page 36 Raw materials......Page 37 Personnel/Manpower......Page 38 Sterilization Process......Page 39 Types of Sterilization Techniques......Page 40 Dose Response Curve......Page 41 References......Page 44 Part II TISSUE BANKING......Page 46 Historical Development......Page 48 Allograft Transplantation......Page 49 Ethical issues......Page 50 Cultural issues......Page 51 Myanmar......Page 52 Singapore......Page 53 Japan......Page 54 Malaysia......Page 55 Indonesia......Page 56 Hong Kong......Page 57 Sri Lanka......Page 58 India......Page 59 Tissue Banking in the Asia-Pacific Region......Page 60 Curriculum update......Page 63 Workshop/Training courses held by the IAEA......Page 64 Development of internet diploma course in tissue banking......Page 65 Post-IAEA ERA: Gloom for Asia-Pacific Region......Page 66 Korean national training course......Page 67 Presidents of the APASTB......Page 71 Current office bearers of the APASTB, 2006–2008......Page 72 World congresses on tissue banking......Page 73 Threat of tissue engineering......Page 74 Factors influencing the development of tissue banking in the Asia-Pacific region......Page 75 References......Page 76 Ethical Issues......Page 78 Religious Issues......Page 79 Islam......Page 80 Christianity......Page 83 Legal Issues......Page 84 India......Page 85 Malaysia......Page 86 Japan......Page 87 Countries with no law......Page 88 References......Page 89 Religious and cultural issues......Page 90 Demand for tissue transplantation......Page 91 Building design......Page 92 Advisory board......Page 94 Tissue bank committee......Page 96 Management committee......Page 97 Dry processing laboratory......Page 98 Equipment costs......Page 100 Financial Considerations......Page 103 Conclusion......Page 104 References......Page 105 Introduction......Page 106 IAEA/RCA Program on Radiation Sterilization of Tissue Grafts (RAS 7/008)......Page 107 NUS Diploma Course in Tissue Banking......Page 108 IAEA/NUS diploma courses held......Page 110 Technology transfer to Africa......Page 111 Curriculum update......Page 112 Development of the NUS Internet Diploma Course......Page 113 Requirements for internet course......Page 114 Current status of the internet diploma course in tissue banking......Page 115 Delivery packages of the online course......Page 116 National Training Programs......Page 117 Acknowledgments......Page 118 References......Page 119 Part III BASIC SCIENCE OF RADIATION......Page 120 Introduction......Page 122 Interaction of Ionizing Radiation with Aqueous System......Page 123 Radiolysis of water......Page 124 Collagen......Page 126 Soft tissues......Page 127 Bone and musculoskeletal tissues......Page 128 Conclusion......Page 129 References......Page 130 Types of Radiation......Page 132 Electromagnetic radiation......Page 133 Source strength......Page 134 Industrial Irradiators......Page 135 Components for Irradiation Facilities......Page 136 Good Radiation Practice (GRP)......Page 137 Irradiator......Page 138 Dosimeters......Page 139 Dose mapping......Page 140 References......Page 141 Introduction......Page 144 Radiation Effects......Page 145 Indirect action......Page 147 Repair of Damaged DNA......Page 148 Radiation Response......Page 149 Factors Influencing Response to Radiation......Page 151 Oxygen......Page 152 Nutrient or organic substrates......Page 153 Bioburden......Page 154 References......Page 155 Introduction......Page 156 Viral diseases (Table 1)......Page 158 Prion diseases (Table 2)......Page 160 Zoonotic Viruses......Page 161 Effects of Radiation on Viruses and Prions......Page 164 Future Prospects of Using Irradiation to Eliminate Viruses and Prions......Page 167 References......Page 168 Introduction......Page 170 Compressive Properties of Bone......Page 171 Tensile Strength of Bone......Page 172 Torsion of Bone......Page 173 Summary......Page 175 Conclusion......Page 176 References......Page 177 Introduction......Page 178 Processing of Amniotic Membrane......Page 180 Moisture content......Page 181 Water vapor transmission rate (WVTR)......Page 182 Results of physical properties......Page 183 Mechanical Properties......Page 185 References......Page 190 Part IV PROCESSING AND QUALITY CONTROL......Page 192 Introduction......Page 194 Dosimetry System......Page 195 Classes of dosimeters......Page 196 Calibration of routine dosimeters......Page 197 Elements of Process Qualification......Page 199 Dose mapping......Page 201 Product validation......Page 206 Routine dose control......Page 207 References......Page 208 Introduction......Page 210 Dose Mapping and Validation......Page 212 Dosimeters......Page 213 Material Compatibility......Page 215 Dose Mapping......Page 216 Routine Process Control......Page 218 Frozen tissue products......Page 219 Conclusion......Page 221 References......Page 222 Introduction......Page 224 Methods of Estimating Microbiological Colonies......Page 225 Bioburden......Page 228 Sampling procedure......Page 229 Calculations......Page 230 Case 2: Bioburden......Page 231 Case 1: Process validation......Page 234 Case 2: Bioburden......Page 237 References......Page 239 Introduction......Page 242 Retrieval/Procurement......Page 243 Processing of Bone for the Validation Process......Page 244 Microbiology swab test......Page 245 Cutting......Page 246 Washing......Page 247 Results of validation experiments......Page 248 Validation of moisture content of bone chips/blocks......Page 249 Validation process of demineralized bone by calculating the Ca content......Page 251 Labeling......Page 252 Bioburden determination......Page 254 Verification dose (VD) experiment......Page 255 References......Page 257 Introduction......Page 260 Retrieval......Page 261 Processing......Page 263 Validation of Washing Process of Amnion Membranes (Hilmy et al. 2002)......Page 264 Results of validation experiments (Hilmy et al. 2002)......Page 265 Sampling method......Page 266 Method for bioburden determination......Page 267 Validation results......Page 268 Documentation of Amnion Membranes......Page 269 References......Page 270 Introduction......Page 272 Pasteurization......Page 273 Using Preheated Water Bath at 60C......Page 274 Using Nonpreheated Water Bath......Page 275 Validated Pasteurization Process......Page 278 References......Page 280 Introduction......Page 282 IAEA Code of Practice......Page 284 Samples for Bioburden and Verification Dose Exercises......Page 285 Method A2: Establish Sterilization Dose for Tissues with a Population Different from the Standard Distribution of Resistance (SDR)......Page 286 Method B: Substantiate 25kGy as Sterilization Dose......Page 288 Method C: Substantiate 25kGy as Sterilization Dose......Page 292 Concept of VDmax Approach......Page 293 References......Page 296 Introduction......Page 298 Quality management......Page 300 The basic elements of an appropriate quality management system Organizational structure and accountability......Page 301 Control of processes (SOPs)......Page 302 Record keeping......Page 303 4. Recipient-adverse events and noncompliances......Page 304 Competency......Page 305 Frozen tissue......Page 306 Dehydration method......Page 307 Selection of Potential Donor (IAEA 2002)......Page 308 Exclusion criteria......Page 309 Transmissible disease blood tests......Page 310 Bacteriological studies of donor and tissues......Page 312 Quality Control (Hilmy 2005)......Page 313 Procurement......Page 315 Processing......Page 316 Packaging materials......Page 318 Laboratory for quality control......Page 319 Validation of Radiation Sterilization Dose According to the IAEA Code of Practice (2004) (see chapter 19; Hilmy et al. 2006)......Page 320 Accompanying documentation requirements......Page 323 References......Page 324 Part V CLINICAL APPLICATIONS OF IRRADIATED BONE GRAFTS......Page 326 Introduction......Page 328 Preparation of Gamma-Irradiated Deep-Frozen Large Bone Allografts......Page 329 Selecting the Appropriate Allografts......Page 330 Spinal surgery......Page 331 Hip surgery......Page 332 Benign bone lesions......Page 334 Complications from gamma-irradiated bone allografts......Page 336 References......Page 337 Introduction......Page 340 Procurement and processing......Page 341 Biological properties......Page 342 Clinical Application......Page 344 References......Page 349 Part VI CLINICAL APPLICATIONS OF IRRADIATED AMNION GRAFTS......Page 350 Introduction......Page 352 Benefits of amnion membrane......Page 354 Application of ALS-Radiated and AAS-Radiated Amnions on Several Kinds of Wounds and Ulcers as well as for Dressing onto Postsurgical Wounds in Indonesia......Page 355 Leprosy ulcer......Page 356 Burn wound......Page 358 Diabetic ulcer......Page 359 Wound covering after circumcision......Page 361 Conclusion......Page 362 References......Page 363 Introduction......Page 366 Air-drying method......Page 368 Freeze-drying technique......Page 369 Partial-thickness burns or scalds......Page 370 Discussion on the Clinical Use of Amniotic Membrane as Burn Wound Dressing......Page 371 The Way Ahead......Page 374 Reference......Page 377 Introduction......Page 378 Preparation of Radiation-Sterilized Freeze-Dried Amniotic Membranes (see chapter 17)......Page 379 Freeze-dried amniotic membrane transplantation in corneal ulcer management (Sunarti and Heryati 2006)......Page 380 Method and surgical technique......Page 381 Clinical results and discussions......Page 382 Surgical technique......Page 383 Clinical results......Page 384 Freeze-dried and fresh amniotic membranes with limbal stem cell transplantation in severe conjunctival tumors and corneal defects (Indira et al. 2000)......Page 385 References......Page 386 Introduction......Page 388 Type of amnion preparations available for clinical application......Page 389 Speci.c features of amnion relevant to plastic surgical practice......Page 390 Antibacterial properties......Page 391 Immunosuppressive role of amnion......Page 392 Uses of Amnion in Plastic Surgery......Page 393 Burns and Stevens–Johnson syndrome......Page 394 Adherence of the membrane to the wound surface......Page 396 Adjunct dressing in .ap surgery......Page 397 Traumatic soft tissue injury......Page 398 Base in tissue engineering......Page 399 Conclusion......Page 400 References......Page 401 APPENDICES......Page 404 Appendix 1 Asia Pacific Association of Surgical Tissue Banks (APASTB) Standards for Tissue Banking Aziz Nather, Norimah Yusof, Nazly Hilmy, Yong-Koo Kang, Astrid L. Gajiwala, Lyn Ireland, Shekhar Kumta and Chang-Joon Yim......Page 408 Contents......Page 416 Acknowledgements......Page 412 Preface......Page 414 A 2.100 General......Page 422 A 2.213 Non-Living Donor Consent......Page 423 A 3.120 Authorisation, Licensing or Registration......Page 424 A 3.220 Administrative Director......Page 425 A 3.300 Quality Management System......Page 426 A 3.320 Quality Management......Page 427 A 3.332 Documentation......Page 428 A 3.333 Control of Processes (SOPs)......Page 429 A 3.334 Record Keeping......Page 431 A 3.350 Competency......Page 433 A 3.460 Equipment and Instruments......Page 434 A 3.473 Waste Disposal......Page 435 B 1.221 General Contraindications......Page 436 B 1.400 Cadaveric Donor Autopsy Report......Page 437 B 1.515 Noti.cation of Con.rmed Positive Test Results......Page 438 B 1.522 Optional Blood Tests......Page 439 B 1.620 Bacteriological Bioburden Limits......Page 440 B 2.100 Rationale......Page 441 B 2.233 Aseptic or Clean/Non-Sterile Procurement Techniques......Page 442 B 2.530 Procurement Container Label......Page 443 B 3.120 Process Validation......Page 444 B 3.320 Tissue Container......Page 445 Temperature monitoring of storage:......Page 446 B 3.750 Final Inspection......Page 447 B 4.300 Fresh Tissue......Page 448 B 4.620 Freeze-Drying Controls......Page 449 B 4.820 Irradiation Sterilisation Controls......Page 450 B 4.1010 Other Inactivation Methods......Page 451 B 5.200 Tissue Containers Labelling......Page 452 B 5.400 Tissue Outer Package Labelling......Page 453 B 6.300 Transportation......Page 454 B 6.810 General......Page 455 B 6.1030 Distribution Record......Page 456 ANNEX 1: GLOSSARY......Page 457 ANNEX 2: GUIDELINES OF FACTORS TO BE CONSIDERED FOR DETERMINING RISK FOR HUMAN IMMUNODEFICIENCY VIRUS OR B ORCHEPATITIS......Page 462 ANNEX 4: EXAMPLE OF ALGORITHM FOR CALCULATING THE HEMODILUTION OF A DONOR HAVING RECEIVED BLOOD, BLOOD COMPONENTS, OR PLASMA VOLUME EXPANDERS WITHIN 48 HOURS PRIOR TO DEATH......Page 463 ANNEX 5: REFERENCES AND CONTACT ADDRESSES......Page 464 Appendix 2 International Atomic Energy Agency (IAEA) Code of Practice for the Radiation Sterilization of Tissue Allografts: Requirements for Validation and Routine Control (2004)......Page 466 Preamble......Page 470 1. Introduction......Page 471 3. Scope......Page 473 5. Definitions......Page 474 7.1. General......Page 477 7.3. Qualification of tissue donors......Page 478 7.4. Qualification of tissue processing and preservation......Page 479 7.5. Maintenance of validation......Page 480 8.1. General......Page 481 8.2. Qualification of the tissue allografts for sterilization Evaluation of the tissue allograft and packaging......Page 482 Technical requirements......Page 483 Product dose mapping......Page 484 10. Documentation and certi.cation procedures......Page 485 11. Management and control......Page 486 Sample item portion (SIP)......Page 487 Bioburden determination......Page 488 Verification dose experiments......Page 489 Selection of dose-setting method......Page 491 a. Establish test sample sizes......Page 493 c. Establish the verification dose......Page 494 e. Interpretation of results......Page 497 Routine use of sterilization doses......Page 498 Procured tissue qualification......Page 499 Typical bioburden distribution......Page 500 Conclusion......Page 501 Procured tissue quali.cation......Page 502 Conclusion......Page 505 Tissue processing and preservation qualification......Page 506 Quali.cation of tissue allografts for sterilization......Page 507 Conclusions......Page 508 Tables 1, 2, 3 and 4......Page 509 Bone......Page 519 HIV......Page 521 Soft tissues......Page 522 Appendix 3 The IAEA Program on Radiation and Tissue Banking — Public Awareness Strategies for Tissue Banks (2002)......Page 524 Contents......Page 528 Preface......Page 526 I. Donor Referral and Transplant Coordination Systems......Page 530 a. Donor Referral......Page 531 b. Transplant Coordination......Page 532 II. Planning a Public Awareness Campaign......Page 533 III. Communication Strategy......Page 534 2. Situation Analysis......Page 535 3. Success Factors......Page 536 4. Objectives......Page 537 c. User Surgeons......Page 538 h. Community Groups......Page 539 6. Selection of Media......Page 540 b. Safety Is the First Priority......Page 541 8. Delivering Strategic Messages......Page 542 10. Crisis Management......Page 547 10.3. Result of Inaction......Page 548 e. Decide What Will Be Said......Page 549 10.8. Work Out What You Will Communicate......Page 550 IV. Public Awareness Campaigns......Page 551 IV.1. Potential Public Awareness Activities......Page 552 IV.2. Tables......Page 553 V. Using the Media......Page 559 1. The Audience......Page 560 3. Case Study One — Quit and Win......Page 561 4. Case Study Two — Medic Alert......Page 562 c. Explain How It Will Benefit People......Page 563 c. Are You Talking to Anyone Else?......Page 564 VI. Promotional Tools......Page 565 Index......Page 568